Journal Article

Effectiveness of a web-based education program to improve vaccine storage conditions in primary care (Keep Cool): study protocol for a randomized controlled trial

Viehmann, Anja, Thielmann, Anika, Weltermann, Birgitta M.

2015

Overview

Background Immunization programs are among the most effective public health strategies worldwide. Adequate vaccine storage is a prerequisite to assure the vaccines’ effectiveness and safety. In a questionnaire survey among a random sample of German primary care physicians, we discovered vaccine storage deficits: 16 % of physicians had experience with cold chain breaches either as an error or near error, 49 % did not keep a temperature log, and 21 % did not use a separate refrigerator for vaccine storage. In a recent feasibility study of 21 practice refrigerators, we showed that these were outside the target range 10.2 % of the total time with some single refrigerators being outside the target range as much as 66.3 % of the time. These cooling-chain deficits are consistent with the international medical literature, yet an effective, easy to disseminate, practice-centered intervention to improve storage conditions is lacking. Methods/design This randomized intervention trial will be conducted in a random sample of primary care practices. Based on continuous temperature recordings over 7 days, all practices with readings outside the target range for vaccine storage (+2 °C to +8 °C) will be randomly allocated to a web-based education program or a waiting list control group. The practice physicians and their teams constitute the target population. Participants will be educated about best practices in vaccine storage and will receive a manual including storage checklists and templates for temperature documentation. In all practices, temperatures of the vaccine refrigerators will be monitored continuously using a data logger with a glycol probe as a surrogate for vaccine vial temperature. The effectiveness of the web-based education program will be determined after 6 months in terms of the proportion of refrigerators with vaccine vial temperatures within the target range (+2 °C to +8 °C) during 7-day temperature logging. Secondary outcome parameters include temperature monitoring, no critically low temperatures (≤ -0.5 °C), compliance with storage recommendations, knowledge of good vaccine storage conditions, and assignment of personnel as vaccine storage manager and backup. Discussion Keep Cool will develop and evaluate a web-based education program to improve vaccine storage conditions in primary care and thereby ensure immunization safety and effectiveness. Trial registration DRKS00006561 (date of registration: 20 February 2015)

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V
• Subject: Biomedicine / Checklist / Clinical trials / Cold / Cold Temperature / Computer-Assisted Instruction - methods / Confidence / Drug Stability / Drug Storage - methods / Drug Storage - standards / Education / Education, Medical, Continuing - methods / Family medicine / Family physicians / Feasibility studies / Feedback / Germany / Guideline Adherence / Health aspects / Health Sciences / Humans / Immunization / Internet / Intervention / Medicine / Medicine & Public Health / Methods / Online education / Online instruction / Practice Guidelines as Topic / Practice Patterns, Physicians / Primary care / Primary Health Care - standards / Prospective Studies / Public health / Quality Improvement / Quality Indicators, Health Care / Refrigeration - standards / Refrigerators / Research Design / Statistics for Life Sciences / Study Protocol / Surveys / Temperature / Time Factors / Vaccines / Vaccines - standards / Vaccines - therapeutic use